An expert from Pharmatech Associates offers a glimpse into the evolution of CM and previews a lively discussion during the upcoming CPhI North America event.
During CPhI Worldwide, leaders from two organizations will outline how CM is taking off, potential benefits, and how to clear common obstacles to adoption.
A leader from the company says to ensure medicines keep reaching the patients that need them, the industry must revamp outdated technologies and techniques.
‘Accelerate, accelerate, accelerate’ – a Pfizer executive explains how the integration of continuous manufacturing helped the company deliver drugs to patients faster.
Driven by market demand, De Dietrich develops an API production set that enables continuous manufacturing of molecules that require exothermic chemical reactions.
A consortium between CPI and the University of Strathclyde aims to create a direct compression platform for continuous manufacturing of oral solid dosage drugs.
Sticking is one of the most common issues that is faced in the manufacture of tablets, and may become a more pressing issue once continuous manufacturing is broadly adopted, suggests I Holland’s R&D manager.
After a low cost of manufacturing goal was achieved by a consortium for the development of a bioproduction system for vaccines, Univercells will launch its NevoLine system.
Bernard McGarvey, formerly of Eli Lilly, spoke with us about first principles of engineering in pharma, following his keynote ‘Engineering First Principles Applications to Pharmaceutical Manufacturing.'
This week in-PharmaTechnologist attended AAPS PharmSci360 in Washington, D.C. where discussions and thought-provoking ideas bounced across sessions – here, we highlight some of the most significant.
Nascent next-generation processing technologies are expected to have a significant effect on how drugs are brought to market – faster and more cost-effectively than ever before, says industry expert.
The Aquarius Genesis film coating system is specially designed for continuous manufacturing, but can also be applied to batch processes, says executive.
The US FDA has drawn industry attention to the potential of 3D printing and continuous manufacturing, which it says could “improve drug quality, address shortages of medicines, lower drug costs, and bring pharmaceutical manufacturing back to the US”.
Drug firms need excipients suited to continuous manufacturing according to Dow, which says a better understanding of how products perform when used in round-the-clock production is required.
Industry delegates say the US Food and Drug Administration (FDA) is showing increased support for continuous manufacturing, a stance C-SOPS told us is quality control-driven.
Pfizer says a lack of harmony among regulators made its continuous granulation platform untenable for bulk manufacturing but is positive about using such tech for smaller volumes.
The EMA has cleared Janssen to make the HIV drug Prezista (darunavir) using a continuous manufacturing (CM) process as well as the previously approved batch method.
European regulators’ efforts to develop continuous manufacturing guidelines are not as advanced as their US counterparts according to delegates who attended a conference last month.
Economics, regulatory inexperience and a lack of technical skills are holding back drug industry adoption of continuous manufacturing says CMAC industrial director, Craig Johnston.
Regulations, recruitment and facility refits are holding continuous manufacturing back, but a Rutgers’ associate behind J&J’s recent success believes industry can overcome these hurdles.
Rutgers leading continuous manufacturing guidance efforts
Industry will be encouraged to adopt continuous manufacturing methods following the regulatory success of Janssen’s Prezista, says Rutgers University associate director and Interphex speaker Doug Hausner.
Janssen is already working on continuous manufacturing methods for other drugs says Rutgers University which helped develop the new Prezista production process approved by the US FDA.
A lack of scientific talent will hold pharma back from adopting continuous manufacturing despite the imminent opening of regulatory pathways, says an MIT Professor.
Though making the switch from batch to continuous manufacturing may be difficult, costly and time consuming, pharma manufacturers and CMOs should begin to consider the switch as in the long-run it will end up saving companies time, money and space, FDA’s...
How can a pharma company invest in continuous manufacturing without bleeding money when it retreats from a local market? Pfizer’s answer is production pods it can roll out anywhere in the world via helicopter… and pack away again if a market turns.
The US FDA is working with GEA to validate continuous manufacturing as the pharma industry enters “the start of the end” for batch manufacturing, according to GEA.
The US FDA set out its support for properly planned continuous manufacturing during a fascinating opening presentation at the first day of Interphex 2011 in New York, US yesterday.
Novartis has hooked up with the Massachusetts Institute of
Technology (MIT) to fund a project aimed at 'revolutionising'
pharmaceutical manufacturing and doing away with traditional
batch-based production techniques.
